Clinical Trial Review

September 2013 | Volume 12 | Issue 9 | Features | 1068 | Copyright © September 2013


Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit

Interleukin-12 Gene and in Vivo Electroporation- Mediated Plasmid DNA Vaccine Therapy in Treating Patients With Merkel Cell Cancer

Sponsored by OncoSec Medical Incorporated in collaboration with National Cancer Institute, patients receive interleukin-12 gene intratumorally (IT) and undergo electrical discharge around the tumor site for electroporation-mediated plasmid DNA vaccine therapy on days 1, 5, and 8. Patients with unresectable disease may receive a second course of treatment in week 7. Patients with localized disease proceed to definitive treatment as determined by the treating physician starting 2-4 weeks after the first injection. The primary objective is to measure the effect of intratumoral injection of IL-12 plasmid (pIL-12) (interleukin-12 gene) followed by in vivo electroporation (EP) (electroporation-mediated plasmid DNA vaccine therapy) on the local expression of interleukin-12 (IL-12) in the tumor microenvironment in patients with Merkel cell carcinoma (MCC).
Patients must have biopsy-confirmed Merkel cell carcinoma and at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable intratumoral injection and electroporation; the injectable lesion must not be in close proximity to another tissue (eg, nerve, bone) that could put patient safety at risk. Patients who have had prior chemotherapy, investigational therapy or a major surgical procedure within 4 weeks or radiotherapy within 2 weeks prior to first day of treatment and must not be receiving concurrently any other anti-cancer treatment (including topical agents such as imiquimod) or investigational agents, which could potentially interfere with the study treatment and/or study endpoints.
table 1

High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs Periodic Clinical Nodal Observation

Sponsored by University of Pittsburgh, this is a prospective, randomized, non-blinded, controlled trial of high risk head and neck cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment arms. Subjects are eligible patients who are sent to Zitelli & Brodland PC for Mohs micrographic surgery of tumors that meet our high-risk criteria. These patients with clinically-negative lymph node exams will either enter into the arm of nodal observation or the arm of elective management of the neck, which is currently the standard protocol per the UPMC ENT department. The patients in the observation arm will have evaluation and treatment of their lymph nodes if an abnormality is detected clinically. The primary endpoint is disease-specific survival. Secondary endpoints will include overall and disease-free survival, complications, and quality of life measures for each arm.
Inclusion criteria must be greater than 6 mm depth of invasion and greater than 2cm diameter. High-risk locations include any portion of cutaneous lip, ear, temple, and scalp. Exclusion criteria include satellite metastases, clinically abnormal lymph node exam, previous head and neck radiation, and pregnancy.
table 2

A Randomized, Double-Blind Phase II, Study of Gemcitabine Alone or in Combination With Pazopanib for Refractory Soft Tissue Sarcoma

Sponsored by OHSU Knight Cancer Institute in collaboration with GlaxoSmithKline, the purpose of this randomized phase II trial studies how well gemcitabine hydrochloride works with or without pazopanib hydrochloride in treating patients with refractory soft tissue sarcoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether gemcitabine hydrochloride is more effective with or without pazopanib hydrochloride in treating patients with soft tissue sarcoma the primary goal is to investigate whether treatment with gemcitabine (gemcitabine hydrochloride) plus pazopanib (pazopanib hydrochloride) improves the median progression-